JP4874256B2 - Diagnostic device for tubular anatomical structures - Google Patents

Description

Disclosure details

〔Explanation〕
The object of the present invention is a diagnostic device intended for tubular anatomical structures, for example lesions of the intestinal tract. In particular, the present invention relates to a diagnostic device directed to a colon or rectal lesion such as intussusception, stenosis, prolapse, rectal hernia.

  In this field, the necessity of the availability of the following diagnostic devices for the above lesions has been felt. That is, the availability of a diagnostic device that can be manufactured at a limited cost, can be used outside of a hospital or clinical facility, and minimizes discomfort in the patient, for example, avoids pain medication The need for it has been felt. Furthermore, the need for the availability of diagnostic devices that allow verification of the presence and extent of mucosal prolapse has been perceived.

  Diagnostic devices such as flexible colonoscopy and sigmoidoscope with serious defects are known. In general, a colonoscope functions by air insufflation to inflate the intestinal wall to be analyzed. Such air delivery causes great discomfort in the patient's body and frequently requires the use of analgesics. In addition, such air delivery can cause rectal swelling resulting in disappearance of any possible mucosal prolapse, which may become invisible.

  There are also known anoscopes that allow direct viewing of the relevant area and can be of large dimensions, for example with a diameter greater than 2 cm, such anoscopes are painful upon insertion and require relaxation of the sphincter muscles. To do.

  In addition to the great discomfort caused in the patient due to this complexity and the cost of the equipment required, the facilities equipped with such equipment are often only hospitals or clinics, so that most of the diagnostic procedures It is necessary to implement in such an environment.

  The problem in the essence of the present invention is that the structural and operational characteristics of the intestinal tract, in particular the rectum and colon lesions, satisfy the above-mentioned need and eliminate the deficiencies mentioned in connection with the known techniques. To provide a diagnostic device.

  Such a problem is solved by the diagnostic device according to claim 1. The dependent claims refer to further embodiments of the device according to the invention.

  Further properties and advantages of the diagnostic device according to the invention will become apparent from the detailed description of preferred exemplary embodiments reported below. These embodiments are described as non-limiting representations with reference to the accompanying drawings.

  The present invention relates primarily to diagnostic devices directed to tubular anatomical structures, such as lesions of the rectum and colon intestinal tract. In general, the device advantageously includes an elongated structure. This elongated structure extends between the proximal and distal ends and is suitable for insertion into the anatomy to be examined. Means are further provided for locally expanding the wall of the tubular structure coupled with the distal end of the elongated structure. The expansion means is movable between a closed position for introducing the device and at least one open position for visualizing and evaluating the lesion.

  The local inflation means is operatively connected to control means coupled to the proximal end of the elongated structure. These control means are actuated by the operator to open or close the expansion means.

  Furthermore, a visual means suitable for coupling to the elongated structure and reaching the tube expanded by the expansion means is also provided.

  In general, as it applies to any embodiment of the device according to the invention, “proximal” means a device that is conventionally in use and in the vicinity of the operator holding the device and performing the test. "Distally" means either the part or end of the device that is conventionally remote from the operator performing the test in use. Means. Furthermore, the term “advancement” means a movement, preferably a translation, performed from the proximal end to the distal end (eg, along arrow F in FIG. 3). In contrast, the term “withdrawal” refers to movement performed from the distal end to the proximal end performed (eg, along arrow F ′ in FIG. 2), preferably Means translation.

  Hereinafter, some embodiments of such a device will be described, for example, with reference to the accompanying drawings.

  1-3, reference numeral 10 generally indicates a transanal diagnostic device according to a first embodiment. Elements common to the illustrated embodiments are described and described with the same reference numerals.

  Reference numeral 12 denotes an inner tube, which is preferably cylindrical and hollow on the inside. The inner tube 12 can be made of, for example, a semi-rigid material, or a flexible material, such as a plastic material.

  The inner tube 12 extends between the proximal end 12a and the distal end 12b. Proximal end 12a is operably coupled to a handle-shaped grip member 14, for example. More specifically, the inner tube is partially housed in the cylindrical cavity 15 of the grip member 14 and freely slides along its longitudinal axis within the cylindrical cavity 15.

  According to a possible embodiment, two slots 16 are formed in a portion that is diametrically opposed to the inner tube 12 and in the vicinity of the proximal end 12a. More specifically, the slot 16 extends in the circumferential direction with respect to the inner tube 12. Preferably, both slots penetrate the entire thickness of the inner tube 12.

  The distal end 12b of the inner tube is preferably operatively connected to arms or petals 22 that extend longitudinally relative to the inner tube 12. Advantageously, the arm 22 is formed as one piece with the inner tube 12. A possible embodiment of the arm 22 is described below with reference to FIGS.

  Indeed, FIGS. 4-6 show an enlarged detail of the distal end of the diagnostic device.

  According to one possible embodiment, the arm 22 of the inner tube 12 includes a hook 24 that extends substantially radially from the arm. More specifically, the hook 24 has an L-shaped configuration extending from one side of the arm 22 and extending transversely from the arm. In other words, the hook 24 defines a seat that opens laterally on the arm 22. In other words, the hook 24 includes a first extension 24a and a second extension 24b. The first spread 24a extends vertically from the arm 22 toward the hook 24 and toward the outside of the arm. The second extension 24b extends in a direction perpendicular to the first extension and in a transverse direction to the longitudinal extension of the arm 22. Preferably, the length measured along the length of the second spreading arm 22 is longer than the length of the first spreading. Furthermore, the second extension preferably extends along a width measured transverse to the length of the arm. This width is substantially the same as the width of the arm.

  According to a possible embodiment, the free end 22a of the arm has an extension 26 so as to have a greater thickness than the rest of the arm. Advantageously, the extension 26 is arranged in the hook 24.

  The arm 22 is suitable for taking at least two extreme configurations, corresponding to a closed configuration (FIG. 5) and a completely open configuration (FIG. 4). In the closed configuration, the free ends of the arms 22 contact each other and the tip or distal end of the diagnostic device is substantially olive-shaped. In the open configuration, the arms 22 are removed from each other and assume a substantially cup-shaped configuration.

  According to a possible embodiment, at least one of the arms 22 has a detection element or marker 27 therein. These detection elements or markers 27 are preferably listed along the length of the arm to assess the extent of the lesion encountered.

  With reference to the embodiment shown in FIGS. 1-3, the outer tube is generally indicated by the reference numeral 28. In the assembled configuration of the device 10, the outer tube 28 houses the inner tube 12 therein. Further, regarding the outer tube 28, it can be seen that the proximal end portion is indicated by reference numeral 28a and the distal end portion is indicated by reference numeral 28b. According to a possible embodiment, the outer tube 28 can be made of a semi-rigid material or a flexible material, such as a plastic material.

  According to a possible embodiment, the outer tube 28 can have one or more detection elements or markers 30 distributed, for example, along the length of the outer tube itself, so that the above-mentioned inside the anus Measure the insertion length of the device and thus the location of the lesion encountered.

  According to one possible embodiment, the markers 30 have an annular shape arranged to traverse the tube, preferably enumerated and distributed along the length of the outer tube.

  According to a possible embodiment, the proximal end 28 a of the outer tube has an annular rib 29. According to a further embodiment, the proximal end 28a of the outer tube has at least one hole 31, preferably two holes. These holes 31 are arranged diametrically on the outer tube and preferably penetrate the thickness of the outer tube. If both the annular rib 29 and the hole 31 are advantageously provided, the latter is formed in the annular rib.

  Advantageously, the outer tube 28 is shorter than the inner tube 12 so that a portion of the inner tube starting from the proximal end of the inner tube is, for example, in the cylindrical cavity 15 of the gripping member 14. Projecting from the proximal end of the outer tube.

  According to a possible embodiment, the outer tube and the inner tube are partially accommodated in the gripping member 14, more precisely in the cylindrical cavity 15.

  The outer tube distal end 28b is preferably operatively coupled to an arm or petal 32 extending longitudinally relative to the outer tube 28. Advantageously, the arm 32 is formed as one piece with the outer tube 28. 4-6 show in detail possible embodiments of the arm 32 of the outer tube.

  For each arm 22 of the inner tube 12, an arm 32 of the outer tube 28 corresponds, and in the assembled configuration of the device 10, these two associated arms overlap.

  According to one possible embodiment, the arm 22 of the inner tube 12 and the arm 32 of the outer tube 28 allow control of the opening and closing of the arm 32 of the outer tube 28 by opening and closing of the arm 22 of the inner tube 12 in particular. It has a configuration suitable for interconnection using shape-coupling.

  4 to 6, particularly FIG. 6, each arm 32 has a seat 34 on the side surface of the arm 32. This seat 34 is suitable for receiving a part of the hook 24, in particular the first extension 24a. Furthermore, the distal end of the arm 32 has a step 36 suitable for contacting the hook 24, in particular the second extension 24b.

  The mutual assembly of the arm 22 of the inner tube 12 and the arm 32 of the outer tube 28 inserts one tube into the interior of another tube, thereby slightly offsetting the angle of each arm. As the two tubes rotate slightly, the arms 32 of the outer tube enter into the seat defined by the hooks 24. The seat 34 accommodates the first spread 24a, while the second spread 24b contacts the step 36.

  Preferably, the thickness of the step 36 decreases toward the free end of the arm 32.

  The arm 32 of the outer tube 28 is suitable for taking at least two extreme configurations, corresponding to a closed configuration (FIG. 5) and a fully open configuration (FIG. 4). In the closed configuration, the free ends of the arms 32 are in contact with each other, and the tip or distal end of the diagnostic device is substantially olive-shaped. In the open configuration, the arms 32 are detached from each other and assume a substantially cup-shaped configuration.

  The transition between these two open / close extreme positions of the distal end of the device is effected by the relative translation of the inner tube 12 and the outer tube 28. Advantageously, the arm 32 of the outer tube 28 is not in operation and is controlled by the arm 22 of the inner tube both at opening and closing.

  Considering the stationary outer tube and the moving inner tube, the inner tube is advanced along the arrow F so that the inner tube is moved from the closed configuration (FIG. 5) to the opened configuration (FIG. 4). Move to. Indeed, both the first extension 24a and the second extension 24b push each arm 32 of the outer tube to a wider position in the radial direction. Conversely, when the inner tube moves backward along the arrow F ′, the inner tube arm 22 and the outer tube arm 32 move from the open configuration (FIG. 4) to the closed configuration (FIG. 5). To do. Indeed, the first extension 24a of the hook 24 cooperates with the arm 32 of the outer tube 28 within the seat 34, while the second extension 24b closes the corresponding arm 32 of the outer tube 28. To cooperate with the outer surface of the arm 32.

  According to one possible embodiment, a membrane 38, preferably made of a plastic or foldable material, fits on the distal end of the outer tube 28, ie on the arm 32. According to a possible embodiment, the membrane is made of a transparent material.

  1-3 show possible embodiments of the means for causing a relative translation between the inner tube 12 and the outer tube 28. In particular, these means are suitable for translating the inner tube 12 relative to the stationary outer tube 28, but may be provided in other manners.

  The grip member 14 has an elongated opening 49 that allows a connection between the inner tube 12 and the control slide 42. Preferably, the control slide portion has a fork shape, and is thus connected to the inner tube at a portion opposite to the opposite side on the inner tube.

  In particular, the control slide 42 has an end that is suitable for insertion into the slot 16 of the inner tube from the outside of the inner tube. Where the control slide is fork-shaped, the ends of the protrusions include relative pins 44 suitable for insertion into the slot 16.

  The control member 46 is operably coupled to the control slide 42, thereby generating forward and backward movement of the inner tube within the outer tube.

  Advantageously, the control member 46 is configured as a lever with an end connected to the gripping member 14 by a pin 48. The connection between the control member 46 and the control slide 42 is provided by a further pin 50. This pin 50 is mounted on the control member 46 in the intermediate region between the pin 40 and the free end of the control member 46.

  According to one possible embodiment, the gripping member 14 includes a ring 52 for receiving the thumb of the operator's hand.

  According to an advantageous embodiment, in addition to the above, a guide profile 54 is provided that is housed in the longitudinal groove 56 of the gripping member 14. A pin 44 also extends outside the inner tube for insertion into the guide profile 54.

  According to one possible embodiment, the cylindrical cavity 15 of the gripping member 14 is counter-shaped with respect to the annular rib 29 of the outer tube, whereby the outer tube is gripped. Avoiding translation in the member 14. Further, when the hole 31 is provided, the cylindrical cavity 15 may have the pin 58 of the outer tube suitable for insertion into the hole 31, so that the outer tube is connected to the grip member 14. Avoid rotating inside.

  With reference to the embodiment shown in FIGS. 1 to 3, the operator grips the grip member 14 by placing a thumb in the ring 52 and grasping the control member 46 when the ring 52 is present.

  From the open position from FIG. 1 or FIG. 3, the operator rotates the control member 46 by closing the control member 46 toward the grip member body. The control slide part 42 presses the inner pipe 12 backward, and thereby the arms of the inner pipe and the outer pipe as described above are closed. The pin 44 slides freely along the slot 16 in the circumferential direction with respect to the tube. The cylindrical cavity 15 has an extension that allows sufficient translation of the inner tube to effect movement of the arm between the two extreme open / closed positions.

  Referring to the definition of the device according to the present invention, the inner tube and the outer tube define an elongated structure that deploys between a proximal end and a distal end. The length of the elongated structure is variable. As a function of the material from which the inner tube and the outer tube are made, the elongate structure may be semi-rigid or flexible. The arm 22 of the device 10 defines a means for locally expanding the wall of the anatomical structure of interest, which means is coupled to the distal end of the elongate structure. The control means includes an inner tube and an outer tube, one of which can be slid inside the other and the outer tube, and a means for generating this relative translation.

  The device 10 in the closed position is introduced transanally into the patient's rectum / colon, sigmoid / colon by the examining physician or operator. The introduction level of the device 10 can be confirmed using these markers 30 when the markers 30 of the outer tube 28 are present. Insertion of device 10 is facilitated by the olive-shaped distal tip of the device, ie, arms 22 and 32.

  When the device reaches the desired position, the distal end of the device is opened “flower-like”, thereby gradually expanding the area of interest. Hereinafter, description will be made with reference to related embodiments.

  In the above-described operation for opening the distal end of the device 10, the inner tube 12 is translated relative to the gripping member 14 and the outer tube 28, which opens the outer tube into the inner tube and the inner tube 12. The same can be done by translating the grip member.

  The device 10 described above can be used in combination with a visual recognition device (for example, a laparoscope 60). These visual devices are introduced into the inner tube 12 and can be guided toward the appropriately expanded target area by the opening of the arm 22 so that the operator (doctor) can perform various lesions. Existence and range can be confirmed. In other words, the inner tube 12 allows the irradiation element and the optical element to pass through the target area visually.

  Alternatively, device 10 can be combined with an apparatus that includes a colonoscope and an air delivery device available from a professional practitioner.

  By gradually widening the distal end of the device 10 gradually, for example, a mucosal reaction due to defecation imitation can be confirmed.

  The device enables diagnosis of various lesions such as intussusception, stenosis, prolapse, and rectal hernia. The location of the defect can be quantified by a marker placed on the outer tube. The extent of the defect can be quantified as a function of where the mucosa fits along the marker on the arm.

  Furthermore, since the device 10 can move backward or forward when the device 10 is opened and closed, various parts of the cell can be analyzed, and the escape state can be diagnosed.

  From the above description it can be seen how the provision of a diagnostic device according to the present invention makes available a low-cost device useful in the diagnosis of tubular anatomical structures, for example lesions of the colonic-rectal canal. Become. For example, it becomes possible to identify and evaluate lesions such as intestinal obstruction, intussusception, stenosis, prolapse, and rectal hernia.

  It is particularly advantageous to be able to perform diagnosis and quantification of rectal prolapse, since known devices, in particular colonoscopes, cannot diagnose such lesions. In fact, since the colonoscope requires air insufflation, rectal swelling occurs, resulting in disappearance of the mucosal prolapse.

  In addition to the above description, the diagnostic device according to the present invention reduces patient discomfort and can be used without the use of analgesics, so it is much easier to introduce than known devices and provides air delivery. I don't need to worry.

  A further advantage of the diagnostic device according to the present invention is related to the fact that it can be made in a small size, which eliminates the drawbacks of a direct anoscope which is painful and requires sphincter relaxation.

  In addition to the above description, the diagnostic device according to the present invention can be used for outpatients because of its simple structure, easy to use, low cost and no need for analgesic administration. It can also be used outside of the hospital or clinical environment in all cases.

  In particular, it is particularly advantageous to provide a tip or head or distal end that does not cause trauma when inserted in the closed position and when used in the open position.

  Furthermore, the risk that tissue may sag or get caught in the device jaw is minimized or even eliminated.

  Realizing a relatively flexible elongated structure that is configured to be easy to introduce, especially into the sigmoid colon, because the materials from which the inner and outer tubes can be made are diverse. Is possible.

  The use of markers on the outer tube and the arm allows quantification of the insertion depth of the device and quantification of escape, respectively.

  The configuration of the device can limit the risk that extraneous elements may enter the device itself in the closed position.

  The shape in the fully open position is particularly advantageous for initiating a reaction from the sphincter. Furthermore, the shape of the arm is preferably designed to have a maximum radial opening at the distal end of the device.

  It should be understood that modifications and / or additions may be made to what has been described and illustrated above.

  The shapes of the inner tube and the outer tube can be changed from those described and illustrated above. The materials can also vary. For example, in the above embodiment, an arm that has not been operated is provided, that is, the operator controls the opening and closing of the arms 22 and 32. By changing the material, these arms open naturally, and the movement between the closed position and the open position is mainly due to the elastic effect after the doctor makes the inner tube freely slide in the outer tube. The resulting device can be obtained.

  The shape connection between the arms of the inner and outer tubes may also vary. For example, the step 36 or the spread 24b may be omitted.

  The configuration of the distal end of the device, ie, the arms 22 and 32, may be associated with other types of commands or controls for translating the inner tube 12 relative to the outer tube 28. For example, commands similar to those described below for further embodiments of the diagnostic device according to the present invention may be used.

  Similarly, commands for translating the inner tube 12 relative to the outer tube 28 may be used with different embodiments of the distal tip.

  7 and 8 show one possible embodiment of the diagnostic device 10 described above. Specifically, FIGS. 7 and 8 show one possible embodiment of a means for causing relative translation between the inner tube and the outer tube. Elements common to the above embodiment are indicated by the same reference numerals.

  The cylindrical cavity 15 of the grip member 14 is shaped upside down with respect to the annular rib 29 of the outer tube and advantageously has a pin 31 suitable for insertion into the hole of the outer tube. Thereafter, translational and rotational movement of the outer tube relative to the grip member is avoided.

  The parallel movement of the inner tube with respect to the outer tube and the grip member is controlled by a control slide unit 42. The control slide 42 is suitable for turning with respect to the grip member and for interaction with the inner tube. The control slide part 42 is accommodated in the grip member 14 by being inserted into the hole 40.

  Specifically, the control slide portion 42 has a fork shape. The free end of the protrusion is suitable for insertion into the slot 16 of the inner tube. Advantageously, the control slide part 42 pivots relative to the grip member in an intermediate region between the protruding end and the free end of the control slide part.

  The cylindrical cavity 15 of the grip member 14 has a recess 62 that allows the control slide 42 to rotate.

  A method using the embodiment of the diagnostic device is described below. In general, this method is similar to the method of the above embodiment. In other words, the relative translation of the inner tube and the outer tube gradually changes the configuration of the distal end of the device from a closed configuration to a fully open configuration and from a fully open configuration to a closed configuration.

  In the embodiment described below, relative translation between the inner tube and the outer tube is obtained by rotating the control slide 42 relative to the grip member held by the operator. The control slide portion 42 acts directly on the inner tube 12, whereby the grip member is moved forward or backward (arrow F and arrow F ′) as a function of the rotational direction of the control slide portion 42. And rotating with respect to the outer tube.

  Depending on the material, the opening of the arm can be controlled directly by the physician or can be affected by the elasticity of the material.

  The advantages discussed above are also valid in the further embodiments described above. It should be understood that changes and / or additions to those described and illustrated above may be provided.

  In this case, the outer tube can be translated with respect to the inner tube.

  Suitable means for producing a relative translation between the inner tube and the outer tube as described above with reference to FIGS. 7-8 are the distal end of the device, in particular the arm 22. And 32 with any embodiment. For example, the above means can be used with the embodiment shown in FIGS. 4-6, or any other embodiment.

  FIG. 9 shows a further possible embodiment of a diagnostic device according to the invention. For the sake of clarity, elements that are common to the embodiments described above are denoted by the same reference numerals.

  The structure of the outer tube and the connection between the outer tube and the grip member 14 are substantially the same as described above.

  Inner tube 12 includes an end portion 64 fitted over the proximal end of the inner tube. The pin 66 is inserted in a transverse direction between the inner tube and the end portion, so that the inner tube and the end portion are integrated with each other. This end portion has at least one groove 68 extending along the length of the inner tube. Preferably, two grooves 68 are provided and arranged diametrically opposite each other on the end portion. The cylindrical cavity 15 has a lug 70 suitable for insertion into the groove 68 to avoid rotation of the inner tube. The dimensions of the protrusion and each groove are adapted to allow relative translation of the inner tube within the outer tube, thereby allowing the inner tube from the two extreme open / closed configurations. Can be moved.

  The proximal end of end portion 64 has a threaded tube 72.

  The grip member 14 includes a handle 74. This handle 74 is fitted on the proximal end of the gripping member 14 and has a threaded tube therein. This threaded tube is suitable for engagement with the threaded tube at the end portion.

  Preferably, the handle 74 is integrated with a ferrule 78 in which the threaded tube is formed.

  In this embodiment, a laparoscope 60 inserted into the inner tube 12 through the handle 74 can be used.

  For the definition of the device according to the invention, the inner tube and the outer tube define the elongate structure that deploys between a proximal end and a distal end. The length of the elongate structure can be changed. Depending on the material from which the inner and outer tubes are made, the elongated structure may be semi-rigid or flexible. The control means includes an inner pipe and an outer pipe, one of which can be slid inside the other and the outer pipe, and a means for causing this relative translation.

  A method using the embodiment of the diagnostic device is described below. In general, this embodiment is similar to the embodiment described above. In other words, the relative translation of the inner tube and the outer tube gradually changes the configuration of the distal end of the device from a closed configuration to a fully open configuration and from a fully open configuration to a closed configuration.

  In the embodiment described above, relative translation of the inner tube within the outer tube is obtained by rotating the handle 74 relative to the grip member being gripped by the operator. By rotating the handle, the end portion and the inner tube translate relative to the grip member and the outer tube forward or rearward (arrow F and arrow F ′) as a function of the direction of rotation of the handle. .

  The rotation of the inner pipe is avoided by the connection between the protruding portion 70 of the grip member and the groove portion 68 of the end portion.

  Relative translation between the inner tube and the outer tube causes the distal end of the device to open or close depending on the embodiment being used. Indeed, the means for controlling the relative translation between the inner tube and the outer tube as described above can be combined with any means for expanding the distal end of the device. For example, an arm similar to that described in the embodiment illustrated in FIGS. 4-6 or other embodiments can be provided.

  The application mode and the introduction and visual recognition method are the same as those described above for the first embodiment.

  The advantages described above are also valid in the further embodiments described above. It should be understood that changes and / or additions to those described and illustrated above may be provided.

  For all the embodiments shown and described above, different means suitable for changing the configuration of the means for locally inflating the wall of the tubular structure may be provided. For example, in order to change the configuration of the means for locally expanding the wall portion of the tubular structure, means other than the inner tube and the outer tube that can be relatively translated may be provided.

  Those skilled in the art aiming to meet the uncertainties and specific requirements for the preferred embodiment of the diagnostic device as described above will make numerous modifications of the elements without departing from the scope of the following claims. , Element adaptation, and element exchange with other functionally equivalent ones can be performed.

Embodiment
(1) In a diagnostic device (10) for a lesion of a tubular anatomical structure,
A tubular elongate structure (12, 28) that deploys between a proximal end and a distal end and is suitable for insertion into the tubular anatomy;
Means (22, 32) for locally inflating the wall of the tubular anatomical structure coupled with the distal end of the elongate structure, the local inflating means introducing the device Means (22, 32) that are movable between a closed position for and at least one open position for visualizing and evaluating said lesion;
Control means coupled to the proximal end of the elongate structure, wherein the control means is operatively connected to the local inflation means, so that between the closed position and the open position; And means for moving the local expansion means between the open position and the closed position;
A diagnostic device.
(2) In the diagnostic device according to embodiment 1,
A viewing means suitable for being coupled to the tubular elongate structure and reaching the tube of the tubular anatomical structure being inflated by the inflation means;
A diagnostic device.
(3) In the diagnostic device according to embodiment 2,
The diagnostic device, wherein the tubular elongated structure is hollow to receive the visual means.
(4) In the diagnostic device according to any one of Embodiments 1 to 3,
The local expansion means is
An arm or petal (22) coupled to the inner tube (12);
An arm or petal portion (32) coupled to an outer tube (28) that houses the inner tube (12) therein;
Including
The arm (32) coupled to the outer tube (28) and the arm (22) coupled to the inner tube (12) are connected to each other by a shape connection, whereby the inner tube and Diagnostic device in which the opening or closing of the arms (22, 32) corresponds to the relative translation of the outer tube.
(5) In the diagnostic device according to embodiment 4,
A diagnostic device, wherein the distal end (12b) of the inner tube is operably coupled to the arm or petal portion (22) formed as one piece with the inner tube (12).

(6) In the diagnostic device according to any one of embodiment 4 or embodiment 5,
The arm (22) of the inner tube (12) includes a hook (24) extending toward the outside of the arm;
The diagnostic device, wherein the hook (24) is suitable for receiving a connecting portion of the arm (32) of the outer tube (28).
(7) In the diagnostic device according to embodiment 6,
The hook (24) has an L-shaped configuration,
The diagnostic device, wherein the L-shaped configuration extends from one side of the arm (22) and extends laterally out of the arm.
(8) In the diagnostic device according to any one of Embodiment 6 or Embodiment 7,
The diagnostic device, wherein the hook (24) defines a laterally open seat on the arm (22) for receiving the arm (32) of the outer tube (28).
(9) In the diagnostic device according to any one of Embodiments 6 to 8,
The hook (24) includes a first extension (24a);
The first extension (24a) extends from the arm in a direction perpendicular to the arm and toward the outside of the arm;
Diagnostic device, wherein the first extension is suitable for being inserted into a seat (34) of the arm (32) of the outer tube.
(10) In the diagnostic device according to embodiment 9,
The hook (24) includes a second extension (24b);
The second extension (24b) extends perpendicular to the first extension (24a) and transverse to the arm (22);
The diagnostic device, wherein the second extension is suitable for contacting a step (36) of the arm (32) of the outer tube (28).

(11) In the diagnostic device according to any one of Embodiments 4 to 10,
A diagnostic device, wherein a distal end (28b) of the outer tube is operably coupled with the arm or petal portion (32) formed as one piece with the outer tube (28).
(12) In the diagnostic device according to any one of Embodiments 1 to 11,
Means for generating a relative translation between the inner tube (12) and the outer tube (28) in a gripping member (14);
A diagnostic device.
(13) In the diagnostic device according to embodiment 12,
The means includes a control slide (42),
The control slide (42) has an end connected to the inner tube (12), and controls the translation of the inner tube (12) in the outer tube (28).
(14) In the diagnostic device according to embodiment 13,
The control slide part (42) has a fork shape,
The fork protrusion is connected to the inner pipe (12), the diagnostic device.
(15) In the diagnostic device according to embodiment 14,
The diagnostic device, wherein the protrusion of the fork is suitable for being inserted into a slot (16) of the inner tube (12).

(16) In the diagnostic device according to any one of Embodiments 13 to 15,
Diagnostic device wherein the control slide (42) is pivoted on the grip member (14) and has an external end of the grip member, thereby being controlled by an operator.
(17) In the diagnostic device according to any one of Embodiments 13 to 16,
The control slide (42) is turned on a control member (46) that is turned on the grip member (14),
Diagnostic device wherein the control member (42) has an external end of the grip member and is thereby controlled by the operator.
(18) In the diagnostic device according to any one of Embodiments 13 to 17,
A diagnostic device in which a guide profile (54) is provided in the grip member (14), thereby allowing the end of the control slide (42) to slide.
(19) In the diagnostic device according to embodiment 12,
The means includes a screw / nut between the inner tube suitable for translation within the grip member (14) and a handle (74) fitted over the proximal end of the grip member (14). A diagnostic device including a screw connection.
(20) In the diagnostic device according to embodiment 19,
The handle (74) includes a threaded tube (76) suitable for connection with a threaded tube (72) coupled to the inner tube (12);
The diagnostic device, wherein the inner tube is fastened inside the grip member, thereby allowing only relative translation of the inner tube.

(21) In the diagnostic device according to embodiment 20,
The inner tube includes an end portion (64);
The diagnostic device, wherein the end portion (64) is integral with the inner tube and incorporates the threaded tube (72).
(22) In the diagnostic device according to embodiment 21,
The diagnostic device, wherein the end portion includes a groove (68) suitable for receiving a protrusion (70) of the grip member (14).

FIG. 1 is an exploded perspective view of a possible embodiment of a diagnostic device according to the present invention. FIG. 2 shows a side view of the diagnostic device from FIG. 1, with some details omitted to highlight other details. FIG. 3 shows the diagnostic device from FIG. 2, which is in different operating states. FIG. 4 shows a perspective view of the details of the distal end of the diagnostic device according to the invention, which is in a first operating state, according to a possible embodiment. FIG. 5 shows a perspective view of the detail from FIG. 4 in the second operating state. FIG. 6 shows an exploded perspective view of the two components in detail from FIG. 4 or FIG. FIG. 7 is a partially exploded perspective view of a possible embodiment of a diagnostic device according to the present invention. FIG. 8 shows a perspective view of details during assembly of the diagnostic device from FIG. 7, with some details omitted to highlight other details. FIG. 9 is a partially exploded perspective view of a possible embodiment of a diagnostic device according to the present invention.

Claims (24)

In a diagnostic device (10) for a lesion of a tubular anatomical structure,
A tubular elongate structure (12, 28) that deploys between a proximal end and a distal end and is suitable for insertion into the tubular anatomy;
Means (22, 32) for locally inflating the wall of the tubular anatomical structure coupled with the distal end of the elongate structure, the local inflating means introducing the device Means (22, 32) that are movable between a closed position for and at least one open position for visualizing and evaluating said lesion;
Control means coupled to a proximal end of the elongate structure, the control means being operatively connected to the local inflation means, thereby between the closed position and the open position; Means for moving said local expansion means;
With
The local expansion means is
An inner pipe (12), and an outer pipe (28) for accommodating the inner pipe (12) therein,
A plurality of inner arms or petals (22) connected to the distal end (12b) of the inner tube (12) and a plurality of connected to the distal end (28b) of the outer tube (28) An outer arm or petal (32);
Including
The inner arm or petal portion (22) and the outer arm or petal portion (32) are connected to each other by a shape connection, whereby the inner tube (12) is translated by the parallel movement of the inner tube (12). Diagnostic device, characterized in that the arms (22, 32) open and close. The diagnostic device of claim 1, wherein
A viewing means suitable for being coupled to the tubular elongate structure and reaching the tube of the tubular anatomical structure being inflated by the inflation means;
A diagnostic device. The diagnostic device according to claim 2,
The diagnostic device, wherein the tubular elongated structure is hollow to receive the visual means. The diagnostic device according to any one of claims 1 to 3,
The inner arm or petal portion (22) and the outer arm or petal portion (32) extend distally beyond the distal ends (12b, 28b) of the inner and outer tubes (12, 28). The inner arm or petal portion (22) and the outer arm or petal portion (32) are at a distance from the distal ends (12b, 28b) of the inner and outer tubes (12, 28). Are connected to each other by a shape connection, so that the distal translation of the inner tube (12) relative to the outer tube (28) opens the arms (22, 32) and the outer tube (28). ), The proximal translation of the inner tube (12) relative to the arm (22, 32) closes. The diagnostic device according to claim 4, wherein
A diagnostic device wherein the distal end (12b) of the inner tube is operably coupled with the inner arm or petal portion (22) formed as one piece with the inner tube (12). The diagnostic device according to any one of claims 4 or 5,
The inner arm (22) of the inner tube (12) includes a hook (24) extending toward the outside of the inner arm,
Diagnostic device, wherein the hook (24) is suitable for receiving a connecting portion of the outer arm (32) of the outer tube (28). The diagnostic device according to claim 6 ,
The hook (24) has an L-shaped configuration,
The diagnostic device, wherein the L-shaped configuration extends from one side of the inner arm (22) and extends transversely out of the arm. The diagnostic device according to any one of claims 6 or 7,
The diagnostic device, wherein the hook (24) defines a laterally open seat on the inner arm (22) for receiving the outer arm (32) of the outer tube (28). The diagnostic device according to any one of claims 6 to 8,
The hook (24) includes a first extension (24a);
The first extension (24a) extends from the inner arm in a direction perpendicular to the inner arm and towards the outside of the inner arm;
Diagnostic device, wherein the first extension is suitable for being inserted into a seat (34) of the outer arm (32) of the outer tube. The diagnostic device according to claim 9, wherein
The hook (24) includes a second extension (24b);
The second extension (24b) extends perpendicular to the first extension (24a) and transverse to the inner arm (22);
The diagnostic device, wherein the second extension is suitable for contacting the step (36) of the outer arm (32) of the outer tube (28). The diagnostic device according to any one of claims 4 to 10,
A diagnostic device, wherein a distal end (28b) of the outer tube is operably coupled to the outer arm or petal portion (32) formed as one piece with the outer tube (28). The diagnostic device according to any one of claims 1 to 11,
Means for generating a relative translation between the inner tube (12) and the outer tube (28) in a gripping member (14);
A diagnostic device. The diagnostic device of claim 12,
The means for generating relative translation between the inner tube (12) and the outer tube (28) includes a control slide (42);
The control slide (42) has an end connected to the inner tube (12), and controls the translation of the inner tube (12) in the outer tube (28). The diagnostic device of claim 13,
The control slide part (42) has a fork shape,
The fork protrusion is connected to the inner pipe (12), the diagnostic device. The diagnostic device according to claim 14, wherein
The diagnostic device, wherein the protrusion of the fork is suitable for being inserted into a slot (16) of the inner tube (12). The diagnostic device according to any one of claims 13 to 15,
Diagnostic device wherein the control slide (42) is pivoted on the grip member (14) and has an external end of the grip member, thereby being controlled by an operator. The diagnostic device according to any one of claims 13 to 16,
The control slide (42) is turned on a control member (46) that is turned on the grip member (14),
Diagnostic device, wherein the control member (46) has an external end of the grip member and is thereby controlled by the operator. The diagnostic device according to any one of claims 13 to 17,
A diagnostic device in which a guide profile (54) is provided in the grip member (14), thereby allowing the end of the control slide (42) to slide. The diagnostic device of claim 12,
The means for generating a relative translation between the inner tube (12) and the outer tube (28) comprises: the inner tube suitable for translation within the grip member (14); and the grip member A diagnostic device comprising a screw / nut screw connection between a handle (74) fitted over the proximal end of (14). The diagnostic device of claim 19,
The handle (74) includes a threaded tube (76) suitable for connection with a threaded tube (72) coupled to the inner tube (12);
The diagnostic device, wherein the inner tube is fastened inside the grip member, thereby allowing only relative translation of the inner tube. The diagnostic device of claim 20,
The inner tube includes an end portion (64);
The diagnostic device, wherein the end portion (64) is integral with the inner tube and incorporates the threaded tube (72). The diagnostic device of claim 21, wherein
The diagnostic device, wherein the end portion includes a groove (68) suitable for receiving a protrusion (70) of the grip member (14). The diagnostic device according to claim 6,
The inner tube (12) can be inserted into the outer tube (28) by the angular offset of the inner arm (22) relative to the outer arm (32);
Due to the mutual rotation of the inner tube and the outer tube (12, 28), the hook (24) of the inner arm (22) engages the corresponding connecting portion of the outer arm (32), thereby the shape connection. A diagnostic device is formed. The diagnostic device of claim 1, wherein
A distal translation of the inner tube (12) relative to the outer tube (28) opens the outer arm (32), thereby separating the distal free end of the outer arm (32);
Diagnosis wherein proximal translation of the inner tube (12) relative to the outer tube (28) closes the outer arm (32), thereby causing the distal free ends of the outer arm (32) to contact each other. device.

Images